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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-350-14
Device Problems Activation, Positioning or SeparationProblem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Loss of Vision (2139)
Event Date 08/17/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a patient adverse event following implantation of a pipeline flex with shield. The patient underwent a procedure for flow diversion to treat an unruptured saccular aneurysm of the c7 segment of the left internal carotid artery. The aneurysm max diameter was 6mm and the neck diameter was 4mm. Vessel tortuosity was normal. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline was successfully implanted. Post-operative angiographic results showed aneurysm occlusion status raymond and roy class 1. Neck coverage and wall apposition were achieved. Post-operatively, the patient experienced fatigue and blindness. Fatigue was considered related to the procedure and blindness was considered to be both procedure and device related. At time of the follow up, the patient's fatigue had resolved and blindness was resolving. No additional medical or surgical treatment was provided related to the patient's symptoms.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key10825047
MDR Text Key215890065
Report Number2029214-2020-01120
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-350-14
Device Catalogue NumberPED2-350-14
Device Lot NumberA854833
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/11/2020 Patient Sequence Number: 1
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